PIP implant advisory and frequently asked questions
Advisory to GPs and other health professionals
Updated 6 June 2012
PIP implants possibly made with non-medical grade silicone have been implanted in eighteen patients in New Zealand, according to the latest information.
The Ministry acknowledges the concern for these women who should be properly supported by the surgeons that performed the implantations.
The implants were carried out by one surgeon who imported the devices in 2003, prior to the creation of Medsafe's medical device database. The Wellington-based surgeon has now retired.
The Ministry advice to health professionals who have one of these women as their patient is:
- Treat as per usual for any patient with a breast implant
- For any concerns, information (implant brand) or further treatment refer to their treating surgeon in the first instance
- If this option is not available, treat as per usual for patient with breast implant and where appropriate refer to the local DHB breast service
- Treatment by the breast service would be on the same basis as treatment of any other individual with a breast implant – on the basis of clinical need.
Treatment, as per any breast implant patient, may require:
- a MRI scan to check for rupture or leaks – although the rupture rate for the PIP implants is regarded as no greater than for other similar products
- removal should be considered where a leak or rupture is detected, inflammation is present or there are other clinical reasons.
- Unless replacement is part of the usual publicly funded service for this patient’s condition, this would not be provided.
- For more specific advice health professionals should contact Healthline 0800 611 116.
New Zealand’s advice is in line with similar advice given in the United Kingdom.
Generally patients that have privately funded medical treatment should continue with their private treatment for any follow up.
- The PIP implants failure rate (rupture or leak) of around 0.4 per cent for every year of implant is comparable to other similar implants.
- The French regulator leading the investigation into this matter, has now confirmed earlier UK findings that there is no evidence of toxicity with the filler used inside the implants. This reassurance should be cautioned by the limited level of knowledge at this stage.
There are no PIP implants entered in the New Zealand medical devices notification database (in place since 2004) and the Australian distributor confirmed that the implants were not marketed or distributed in New Zealand.
Medsafe will continue to monitor the safety of PIP implants.
Other information from:
The Australian regulator TGA (including advice to patients):